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A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
First received: February 5, 2009
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Biological: albiglutide
Drug: insulin glargine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline


Secondary Outcome Measures:
  • FPG change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline

  • body weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline


Enrollment: 779
Study Start Date: February 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide weekly injection Biological: albiglutide
albiglutide weekly injection
Active Comparator: insulin glargine Drug: insulin glargine
insulin glargine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • BMI 20-45kg/m2 inclusive

Exclusion Criteria:

  • females who are pregnant, lactating or within <6 weeks post-partum
  • current symptomatic heart failure (NYHA Class III-IV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838916

  Show 334 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
Study First Received: February 5, 2009
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013